Clinical Trials Directory

Trials / Completed

CompletedNCT03148561

Management of Women With an Incomplete Miscarriage

Misoprostol Versus Expectant Management in Women With Incomplete First-trimester Miscarriage After Misoprostol Treatment: A Randomized Clinical Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
84 (actual)
Sponsor
Assiut University · Academic / Other
Sex
Female
Age
20 Years – 40 Years
Healthy volunteers
Not accepted

Summary

Miscarriage is defined as the spontaneous loss of a pregnancy before 24 weeks' gestation, that is, before the fetal viability. The clinical signs of miscarriage are usually vaginal bleeding associated abdominal pain and cramping . The miscarriage is named 'complete' or 'incomplete' according to whether or not tissues are retained in the uterus. If a woman has minimal bleeding but her cervix is closed, this is known as a 'threatened miscarriage. However; if the pregnancy is still inside the uterus but the cervix is open, this is described as an 'inevitable miscarriage', which it will not usually be possible to save the fetus. From many years, the surgical curettage ('evacuation of the uterus') was considered the 'gold standard management' for miscarriage to remove the retained placental tissue. It is quickly performed and removed almost all the retained products of conception. However, the routine surgical evacuation of the uterus associated with higher rate of morbidity and mortality and should be limited for special indications. Many studies compared the effectiveness of medical treatment compared to surgery in management of incomplete abortion. There is only one study compared the curettage with expectant management in those women after medical therapy.However; none of them, looked at the effectiveness of the second chance of medical treatment in management of incomplete abortion in trial to avoid the surgical intervention after failure of previous medical treatment. So we think that the immediate evacuation using surgical intervention is truly unnecessary in most cases of failed medical abortion and the patients may get benefit from another trial of medical treatment.

Conditions

Interventions

TypeNameDescription
DRUGMisoprostolreceived misoprostol 800 µg (Misotac 200 µg tablets, SIGMA pharmaceutical) once dose vaginally

Timeline

Start date
2017-07-01
Primary completion
2019-07-01
Completion
2019-07-01
First posted
2017-05-11
Last updated
2020-07-21

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT03148561. Inclusion in this directory is not an endorsement.